在售医用口罩关键参数的检测与分析  

Detection and Analysis of Key Parameters of Medical Masks on the Market

作　　者：罗洋 张述 董双鹏[1] LUO Yang;ZHANG Shu;DONG Shuang-peng(Tianjin Medical Devices Quality Supervision and Testing Center,Tianjin 300384)

机构地区：[1]天津市医疗器械质量监督检验中心,天津300384

出　　处：《中国医疗器械信息》2023年第17期44-46,66,共4页China Medical Device Information

摘　　要：目的:根据相关国家和行业标准,对已上市的一次性医用防护口罩、一次性医用外科口罩和一次性医用口罩进行相关检测分析,评价市面上口罩的整体质量,为上市后监管提供参考。方法:按照YY/T 0969-2013《一次性使用医用口罩》、YY0469-2011《医用外科口罩》和GB19083-2017《医用防护口罩技术要求》,对口罩关键参数如口罩带、过滤效率、气流阻力、合成血液穿透阻力和环氧乙烷残留量等进行检测。结果:随机抽取的69批产品中有9批不合格。结论:抽取的在售口罩有超过10%的产品检测不符合相应的标准。Objective:The aim of this article is to test the performances of the disposable medical protective respirators,disposable surgical masks and disposable medical masks,so as to evaluate the overall quality of masks on the market and provide references for post-marketing supervision.Methods:According to YY/T 0969-2013“Disposable Medical Masks”,YY 0469-2011“Medical Surgical Masks”and GB 19083-2017“Technical Requirements for Medical Protective Masks”,the key parameters of masks such as mask band,filtration efficiency,airflow resistance,synthetic blood penetration and residual ethylene oxide were tested.Results:Out of 69 batches randomly selected,9 batches were unqualified.Conclusion:Above 10%of mask products on the market do not meet the corresponding standards.

关 键 词：医用防护口罩 医用外科口罩 医用口罩 国家标准 行业标准 

分 类 号：TH771[机械工程—仪器科学与技术]